Summary of the context and overall objectives of the project

The main objective of ZipPrime’s H2020 Phase-01 project entitled “Reusable Next Generation Sequencing (NGS) Library Storage Technology for Clinical Applications” was to prepare a feasibility study to asses the requirements for the commercialization of ZipPrime’s technology.The context and overall objectives of the project were:To deliver a detailed and reliable market research, patent landscape analysis and technology opportunity analysis (TOP).To deliver a specific intellectual property (IP) strategyTo analyse the regulatory requirements in regard with quality management systems (QMS) and technology validation.To explore and exploit possible collaboration opportunities with academicians and clinicians, private sector representatives, University Hospitals and civil society organizations.To deliver detailed marketing, business and technology strategies.To deliver a detailed economic feasibility in the form of financial projections, balance sheet projections, income statement projections and cash flow projections.To come with an overall conclusion to whether the project idea should be followed and why.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

ZipPirme used their core management team and associated to undertake the work required during the project. A detailed market research, patent landscape analysis and technology opportunity analysis (TOP) has been conducted. For the delivery of a specific intellectual property (IP) strategy, a freedom to operate (FTO) report was prepared together with reputable patent offices.Analysis on the regulatory requirements were conducted along with a CRO company. As a result, a clinical validation study plan was asserted and regulatory requirements needed for the technology demonstration and commercialization ZipPirme’s technology were determined.Collaborations with academicians and clinicians, private sector representatives, University Hospitals and civil society organizations were started.Possible customers and key stakeholders have been identified.Possible collaboration opportunities with academicians and clinicians, private sector representatives, University Hospitals and civil society organizations have been exploited.Detailed business, technology and marketing roadmaps have been delivered. Company also benefited from the coaching support under SME Instrument and had a 3 days coaching from during which a highly focused analysis on the NGS-based diagnostics market, possible applications of ZipPrime’s technology, marketing strategies, regulations, possible customers and competitors has been performed.A detailed economic feasibility in the form of financial projections, balance sheet projections, income statement projections and cash flow projections has been delivered.Feasibility study revealed that both and the disruptiveness level the uniqueness of ZipPrime’s technology scores 9 out of 10 of the technology scores 9 out of 10.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The feasibility study revealed that ZipPrime’s technology addresses an EU-wide challenge in the healthcare biotechnology sector: “the adaptation of rapid NGS uptake in the clinical environment”. Clinical tests should establish accuracy, precision, reportable range, reference range, analytical sensitivity, analytical specificity, and other performance characteristics, as applicable. Regulators ask for the development a standard for preventing false-positive and false-negative test results. Because a false positive could cause undue patient anxiety, while a false negative could lead a patient’s diagnosis to go untreated. For this purpose validation (platform, test and informatics validations) and quality control should be applied. There currently is a lack of a validated solution to ensure the validation and quality control of clinical data delivered through NGS. The lack of such a validated solution will become a bottleneck for NGS in healthcare setting. ZipPrime’s technology offers a solution to this challenge with its patented Reusable NGS Library Storage Technology, addressing an unmet market need, a new market opportunity for ZipPrime. The feasibility study also revealed that the growth of ZipPrime’s solution scores 8 out of 10, the addressable market size –based on current technology scores 9 out of and the projected market size – subject to bridging of tech. gaps- for ZipPrime’s technology scores 8 out of 10.